At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 461 enrolled

Drug / intervention

Lacosamidedrug

Likely dose

Lacosamide 50 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00955357

NCT00955357Phase 4Completed

Compare CT.gov

An Open-Label, Multicenter, Multinational Study of Lacosamide as First Add-On Anti-epileptic Drug (AED) Treatment in Subjects With Partial-Onset Seizures

UCB Pharma·interventional·Posted Aug 10, 2009·Updated Jul 17, 2018

In Brief

A Phase 4 clinical trial evaluating Lacosamide for Partial Epilepsies. Completed, enrolled 461 participants across 109 sites in 15 countries.

Detailed Summary

To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPartial Epilepsies

CountriesAustria, Bulgaria, Czechia, Denmark, Finland, France, Greece, Italy, Mexico, Romania, Russia, Spain, Switzerland, Turkey (Türkiye), United States

Collaborators--

Timeline

Phase 4CompletedFinished

20102011201220132014201520162017201820192020202120222023202420252026

Enrollment StartAug 2009

First PostedAug 2009

Primary CompletionApr 2013

Study CompletionAug 2013

TodayJul 2026

First PostedAug 10, 2009

Enrollment StartAug 1, 2009

Primary CompletionApr 1, 2013

Study CompletionAug 1, 2013

TodayJul 2, 2026

Enrollment to primary: 3.7 yearsPosted 16.9 years ago

Interventions

Lacosamidedrug

Oral Lacosamide: Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week